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510(k) K021194

RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM by Hemagen Diagnostics, Inc. — Product Code DCK

K021194 is an FDA 510(k) premarket notification submitted by Hemagen Diagnostics, Inc. for the device "RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 29, 2002. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Hemagen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2002
Date Received
April 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Hemagen Diagnostics, Inc.

  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K041052 — RAICHEM GLUCOSE UV (LIQUID) (June 30, 2004)
  • K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT (June 25, 2004)
  • K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (June 16, 2003)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K022772 — RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (September 17, 2002)
  • K022767 — RAICHEM LIPID CALIBRATOR (September 3, 2002)
  • K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT (July 19, 2002)
  • K012668 — RAICHEM GLUCOSE UV REAGENT (October 15, 2001)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)

Other clearances for product code DCK

  • K242170 — K-ASSAY CRP (Ver.2) (April 18, 2025)
  • K201256 — Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (November 4, 2022)
  • K192028 — Yumizen C1200 CRP (June 25, 2020)
  • K192118 — CRP Vario (November 8, 2019)
  • K191993 — Yumizen C1200 CRP (October 3, 2019)
  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K152433 — VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (September 24, 2015)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)

FDA data resources